Qsymia Diet Drug Approval Raises Safety Worries

Jul 19, 2012 | Parker Waichman LLP

A new prescription obesity and diet drug has been approved for use in the U.S. and like many of its predecessors, there are widespread concerns over its safety.

The Food and Drug Administration this week approved Qsymia as a drug treatment for obesity. While early clinical trials have shown it could cause more weight loss in patients than any drug before it, it contains two ingredients that have been the root of problems for those predecessor drugs.

According to a report from WFAA-TV in Dallas/Fort Worth, Texas, Qsymia contains phentermine, the main ingredient in the controversial diet drug Fen-Phen. Phentermine has been linked to heart palpitations that could cause more severe cardiac problems in the future for patients who continue to take the drug or who suffer from pre-existing heart maladies. A local pharmacist told the station that patients suffering from high blood pressure, diabetes, kidney disease, and thyroid disorder should not take drugs containing phentermine because it could exacerbate the risks of the drug.

In addition to that risk, Qsymia also contains topiramate, an ingredient used in the epilepsy drug Topamax to prevent seizures caused by that disease. Women planning to get pregnant should avoid drugs containing topiramate because it has been linked with causing birth defects - cleft lip and cleft palate - in babies born to mothers who took the drug prior to and during their pregnancy.

Topiramate is also known to reduce the effectiveness of birth control pills.

In approving the drug for use in the U.S., the Food and Drug Administration ordered the makers of it to change its name from Qnexa to Qsymia because its proposed name was too similar to other drugs and that could lead to potentially fatal medication errors.

The weight loss market is highly competitive with millions of Americans considered obese or morbidly obese and the need for a quick fix apparently a must. Often when a patient prescribed a drug to combat obesity does not get the results they expected, they may be eager to try something different or new, putting recent releases to the market in high demand.

The speculation being generated over Qsymia is completely warranted as every other drug that’s been approved for this indication has been subject of the same scrutiny and tied to numerous and dangerous side effects.

Vivus, the makers of Qsymia, is expecting windfall profits from early sales of the drug despite it only being available through mail-order and not at a doctor’s office. That move is considered to have an eye out for caution in widespread dispersal of the drug initially.

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